MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-08-07 for STA-R EVOLUTION IVD COAGULATION DEVICE/INSTRUMENT 58978 manufactured by Diagnostica Stago S.a.s..
[116212980]
(b)(4). Stago will provide a follow-up report(s) once relevant information has become available.
Patient Sequence No: 1, Text Type: N, H10
[116212981]
On (b)(6) 2018: stago hotline received a call from the customer indicating that there were some samples that resulted as
| Report Number | 8043723-2018-00002 |
| MDR Report Key | 7756303 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-08-07 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-07-03 |
| Date Facility Aware | 2018-07-13 |
| Report Date | 2018-08-03 |
| Date Reported to Mfgr | 2018-08-03 |
| Date Mfgr Received | 2018-07-20 |
| Device Manufacturer Date | 2013-02-10 |
| Date Added to Maude | 2018-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR WALID BEN AMMAR |
| Manufacturer Street | 2 RUE PIERRE FOSSATI |
| Manufacturer City | FRANCONVILLE VAL-DOISE, 95130 |
| Manufacturer Country | FR |
| Manufacturer Postal | 95130 |
| Manufacturer G1 | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Street | 125 AVENUE LOUIS ROCHE PAE PARISPACE 3 |
| Manufacturer City | GENNEVILLIERS, 92230 |
| Manufacturer Country | FR |
| Manufacturer Postal Code | 92230 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STA-R EVOLUTION |
| Generic Name | EVOLUTION |
| Product Code | JPA |
| Date Received | 2018-08-07 |
| Model Number | IVD COAGULATION DEVICE/INSTRUMENT |
| Catalog Number | 58978 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DIAGNOSTICA STAGO S.A.S. |
| Manufacturer Address | 125 AVENUE LOUIS ROCHE PAE PARISPACE 3 GENNEVILLIERS, 92230 FR 92230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-07 |